MYOZYME: 82 Adverse Event Reports & Safety Profile
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82
Total FAERS Reports
26 (31.7%)
Deaths Reported
37
Hospitalizations
82
As Primary/Secondary Suspect
9
Life-Threatening
2
Disabilities
First Report: 2007 · Latest Report: 20140605
What Are the Most Common MYOZYME Side Effects?
#1 Most Reported
Pyrexia
16 reports (19.5%)
#2 Most Reported
Pneumonia
10 reports (12.2%)
#3 Most Reported
Death
10 reports (12.2%)
All MYOZYME Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Pyrexia | 16 | 19.5% | 6 | 13 |
| Death | 10 | 12.2% | 10 | 3 |
| Pneumonia | 10 | 12.2% | 1 | 9 |
| Hypotonia | 6 | 7.3% | 3 | 3 |
| Oxygen saturation decreased | 6 | 7.3% | 2 | 3 |
| Respiratory failure | 6 | 7.3% | 2 | 5 |
Who Reports MYOZYME Side Effects? Age & Gender Data
Average age: 17.2 years. Most reports from: BR. View detailed demographics →
Is MYOZYME Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2007 | 3 | 0 | 2 |
| 2008 | 3 | 0 | 1 |
| 2009 | 3 | 1 | 2 |
| 2010 | 1 | 1 | 0 |
| 2011 | 3 | 0 | 3 |
| 2012 | 5 | 1 | 4 |
| 2013 | 16 | 4 | 6 |
| 2014 | 28 | 11 | 14 |
What Is MYOZYME Used For?
| Indication | Reports |
|---|---|
| Glycogen storage disease type ii | 82 |
Official FDA Label for MYOZYME
Official prescribing information from the FDA-approved drug label.